Comparative Effectiveness of Web-based Versus Traditional Adolescent HIV Prevention

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by National Development and Research Institutes, Inc..
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Information provided by:
National Development and Research Institutes, Inc.
ClinicalTrials.gov Identifier:
NCT01142882
First received: June 9, 2010
Last updated: July 19, 2011
Last verified: July 2011
  Purpose

This study will evaluate the comparative effectiveness and cost-effectiveness of a customized, interactive web-based HIV, sexually transmitted infections (STI) and hepatitis prevention intervention as compared to a traditional, educator-delivered prevention intervention. Both interventions will be offered to youth enrolled in outpatient, community-based substance abuse treatment at our collaborating treatment facilities. Outcomes to be measured include accurate HIV/disease prevention knowledge, intentions to engage in safer sex, actual HIV risk behavior, attitudes toward safer sex and self-reported substance use. The web-delivered intervention under evaluation has the potential to deliver evidence-based content at low cost without increasing demands on treatment staff time or training needs.


Condition Intervention
HIV Infections
Hepatitis
Sexually Transmitted Infections
Behavioral: Traditional Prevention
Behavioral: Web-based Prevention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Comparative Effectiveness of Web-based vs. Traditional Adolescent HIV Prevention

Resource links provided by NLM:


Further study details as provided by National Development and Research Institutes, Inc.:

Primary Outcome Measures:
  • HIV/disease prevention knowledge [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • behavioral intentions [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    intentions to engage in safer sex

  • HIV risk behavior [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    sexual risk behavior


Secondary Outcome Measures:
  • skills acquisition [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    communication skills; negotiaion skills & condom use skills

  • self-reported substance use [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    as measured via Timeline Follow-back

  • intervention acceptability [ Time Frame: post-intervention ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: February 2010
Estimated Study Completion Date: August 2011
Estimated Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Traditional Prevention
educator-delivered, small-group HIV & disease prevention education
Behavioral: Traditional Prevention
Participants in the traditional prevention intervention condition will complete two sessions (of approx. one hour in duration) across the course of a week, conducted by a trained HIV (and infectious disease) prevention educator; these sessions will typically be conducted in small groups of 2-4 participants but may be offered individually.
Experimental: Web-based Prevention
self-directed, interactive & customized web-based HIV & disease prevention education
Behavioral: Web-based Prevention
Participants in the web-based intervention condition will complete an interactive, web-based HIV, hepatitis and STI prevention program. Youth will be asked to complete a customized plan of approximately 2-4 hours in length using the web-based tool; participants will complete two 60-minute sessions per week until they complete their customized plan. Participants can choose to access this intervention using dedicated computer stations set up at their substance abuse treatment setting or can complete these sessions at their own home via the web.

Detailed Description:

This trial will examine the comparative effectiveness and cost-effectiveness of a web-based HIV, hepatitis and STI prevention intervention when offered to youth in outpatient, community-based substance abuse treatment as directly compared to a traditional HIV (and infectious disease) prevention intervention. We will assess the comparative effectiveness and cost-effectiveness of these interventions by primarily examining changes from pre- to post-intervention in accurate HIV/disease prevention knowledge, intentions to engage in safer sex and HIV risk behavior. Additionally, we will examine the extent to which the interventions impact relevant skills acquisition (e.g., communication skills, negotiation skills and condom use skills), attitudes toward safer sex and self-reported substance use, as well as the acceptability of each intervention. We also plan to evaluate youth at both 1 and 3 month post-intervention to examine the durability of effects (including any differential durability of effects across intervention conditions). The web-delivered prevention intervention to be evaluated in this study has the potential to allow for a complex intervention to be delivered at a low cost, without increasing demands on staff time or training needs, and may thereby expand the reach of evidence-based prevention for youth in substance-abuse treatment.

This study will be conducted at three collaborating, community-based adolescent substance abuse treatment programs all of which are housed within the Daytop Village network of services and are located in New York City: (1) Daytop Village's Brooklyn Outreach Center; (2) Daytop Village's Bronx Outreach Center; and (3) Daytop Village's Queens Outreach Center. We expect to recruit approximately one third of the total number of participants from each site.

A total of up to 160 (no fewer than 120) adolescent participants will be enrolled in this study. Participants will be randomly assigned to one of the two study conditions in an intent-to-treat design (n=60-80 per group): (1) computer-delivered intervention or (2) traditional (person-delivered intervention). Participants in the traditional prevention intervention condition will complete two sessions (of approx. one hour in duration) across the course of a week, conducted by a trained HIV (and infectious disease) prevention educator; these sessions will typically be conducted in small groups of 2-4 participants but may be offered individually. Participants in the computer-delivered intervention condition will complete an interactive, web-based HIV, hepatitis and STI prevention program instead of the traditional, person-delivered prevention intervention. Youth will be asked to complete a customized plan of approximately 2-4 hours in length using the web-based tool; participants will complete two 60-minute sessions per week until they complete their customized plan. Participants will access this intervention using dedicated computer stations set up at their substance abuse treatment program.

  Eligibility

Ages Eligible for Study:   12 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Enrolled in collaborating adolescent substance abuse treatment program (i.e., Daytop's Brooklyn Outreach Center, Bronx Outreach Center or Queens Outreach Center)
  • 12-18 years of age
  • Within first 30 days of substance abuse treatment (current treatment episode)
  • Not yet received formal HIV prevention intervention during current treatment episode

Exclusion Criteria:

  • Plans to move out of the area within the next 5 months
  • Insufficient ability to understand and provide informed consent/assent to participate
  • Insufficient ability to use English to participate in the consent process, the interventions and/or assessments
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01142882

Contacts
Contact: Honoria M. Guarino, Ph.D. 212-845-4540 guarino@ndri.org

Locations
United States, New York
Daytop Village, Bronx Outreach Center Recruiting
Bronx, New York, United States, 10461
Contact: Cassandra Melnikow, MA    718-518-9007 ext 2112    melnikow@ndri.org   
Daytop Village, Brooklyn Outreach Center Recruiting
Brooklyn, New York, United States, 11217
Contact: Elaine Dillingham, B.A.    718-625-1388 ext 2811    dillingham@ndri.org   
Daytop Village, Queens Outreach Center Recruiting
Jamaica, New York, United States, 11435
Contact: Cassandra Melnikow, M.A.    718-523-4242 ext 2252    melnikow@ndri.org   
Sponsors and Collaborators
National Development and Research Institutes, Inc.
Investigators
Principal Investigator: Lisa A. Marsch, Ph.D. National Development and Research Institutes, Inc.
Study Director: Honoria M. Guarino, Ph.D. National Development and Research Institutes, Inc.
  More Information

No publications provided

Responsible Party: Lisa A. Marsch, Ph.D., National Development and Research Institutes, Inc.
ClinicalTrials.gov Identifier: NCT01142882     History of Changes
Other Study ID Numbers: HIVPrev613, 1RC1DA028415
Study First Received: June 9, 2010
Last Updated: July 19, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by National Development and Research Institutes, Inc.:
adolescent HIV prevention
web-based interventions
adolescent substance abuse treatment
comparative effectiveness research
HIV prevention
hepatitis prevention
STI prevention

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Hepatitis
Hepatitis A
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Enterovirus Infections
Picornaviridae Infections
Infection
Genital Diseases, Male
Genital Diseases, Female

ClinicalTrials.gov processed this record on September 11, 2014